SclerodermaNCT06772896
Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items Among People With Systemic Sclerosis
A study testing Reordered PHQ-8 in people with Scleroderma and Systemic Sclerosis (SSc), run by Lady Davis Institute at 2 sites in Canada.
Trial summary
There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic Sclerosis (SSc), Scleroderma (Limited and Diffuse)
- What is being tested?
- Reordered PHQ-8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 851 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Jan 2025to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English, French or Spanish.
- Participants must have access to a computer or tablet with internet access.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Lady Davis Institute for Medical Research
Montreal, Quebec, H3T 1E2
About this study
Official title: Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items in the 8-item Patient Health Questionnaire Among People With Systemic Sclerosis: A Scleroderma Patient-centered Intervention Network (SPIN) Study
There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease. However, it has been shown in previous studies that biases associated with somatic items do not affect total depression scores. The reason for this is still unclear but could be associated with the context in which these items are presented.
The goal of this experiment is to learn whether the way people with systemic sclerosis answer somatic items on a depression questionnaire is influenced by the fact that they are aware they are being assessed for depressive symptoms.
The main question it aims to answer is: Do people with systemic sclerosis score somatic items differently when they are administered outside the context of a depression questionnaire? Participants will be randomly assigned to complete the 8-item Patient Health Questionnaire as part of their routine cohort assessments either with the items in their standard order or with somatic items presented first and separately from psychological items.
Read the detailed description
- BACKGROUND Most self-report depression symptom questionnaires include both psychological and somatic symptom items. The 9-item Patient Health Questionnaire (PHQ-9) and its 8-item version (PHQ-8) are commonly used depression assessment measures and include items that reflect the psychological and somatic symptoms of depression listed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). However, there is concern that scores obtained using such questionnaires may be inflated in people with chronic illness due to the overlap of somatic symptoms related to depression and those stemming from their physical illness. In contrast to what might be expected, existing research suggests that having a medical illness or the severity of a respondent's medical illness are not associated with higher scores on somatic symptom items of the PHQ-9. Studies conducted in different patient populations, including people with systemic sclerosis (SSc), found either no significant differential item functioning (DIF) in somatic items of depression questionnaires or minimal DIF that did not significantly affect total questionnaire scores. It is possible that people with medical conditions who experience symptoms that may overlap with depression symptoms, including fatigue, changes in appetite, and sleep problems, do not report them on the PHQ-9 or PHQ-8 more than people without medical conditions due to a question ordering or context effect. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a randomized experiment to examine whether awareness that depression symptoms are being assessed affects how people with a chronic illness report somatic symptoms of depression.
- OBJECTIVES The primary objective will be to evaluate differences in mean sum scores of PHQ-8 somatic items (sum of item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite) in people with SSc when the items are administered outside the context of a depression questionnaire compared to when they are administered in the context of a depression questionnaire. The secondary objective will be to evaluate differences in mean scores for each individual somatic symptom item.
- RECRUITMENT The SPIN Cohort is a large multinational cohort that collects longitudinal data on patient-reported outcomes from people living with SSc. It currently includes >1500 active participants recruited from 53 SPIN sites in Canada, the United States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN cohort participants are recruited during regular medical visits at SPIN recruitment sites, and written informed consent is obtained. Once enrolled in the Cohort, participants are sent an automated welcome email with instructions on how to activate their SPIN account and complete SPIN Cohort measures online. Cohort participants complete online assessments upon enrolment and at 3-month intervals. All SPIN Cohort participants who log in to the SPIN Cohort platform to complete a routine 3-month assessment will be included in this experiment.
- RANDOMIZATION The SPIN Cohort platform will be programmed to automatically randomize each participant via simple randomization in a 1:1 ratio to either the "Reordered items" arm or the "Original item order" arm.
- OUTCOMES The primary outcome variable will be the sum score of the 3 PHQ-8 somatic symptom item scores (item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite). The secondary outcome variables will be the individual item scores for items 3, 4, and 5.
- METHODS This is a two-arm parallel randomized controlled experiment. When SPIN Cohort participants log in to complete their routine assessment, they will be randomly assigned to complete either the standard PHQ-8 or a reordered version in which the 3 somatic symptom items (item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite) will be presented first, without any indication that they are part of a depression questionnaire, and the psychological symptom items will be presented later in the assessment protocol. Both primary and secondary analyses will be done as complete case analyses using between-groups t-tests.
- Being tested
- Reordered PHQ-8
- Keywords
- Scleroderma, Systemic Sclerosis, Depression, Patient-reported outcome measure, PROM, Item order
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reordered PHQ-8Other
Participants will be administered the PHQ-8 somatic items separately from the psychological items, outside the context of a depression questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Reordered items | Experimental | Participants will receive a routine assessment protocol in which the 3 PHQ-8 somatic items will be presented separately from and prior to the 5 psychological items, without any indication they are part of a depression symptom questionnaire. PHQ-8 psychological items will be presented after the somatic items and with at least 1 measure separating them in the routine assessment protocol. With the exception of these 2 rules, all measures included in the routine assessment will appear in a random order for each SPIN Cohort participant. Receives: Other: Reordered PHQ-8 |
| Original item order | No intervention | Participants will complete the standard version of the PHQ-8 which includes both somatic and psychological items, presented in a random order among other measures of the routine assessment protocol. The title of the PHQ-8 will not be included and participants will only see the 8 items presented on a single page in their standard order. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean sum PHQ-8 somatic item scores when administered outside and within a depression questionnaire context
Scores obtained on the 8-item Patient Health Questionnaire (PHQ-8) range from 0 to 24, with higher scores indicating worse outcome. Individual items are scored on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). PHQ-8 somatic items will include items 3 (sleep problems), 4 (fatigue), and 5 (changes in appetite). The investigators will compare the mean sum score of somatic item scores between the "Reordered items" arm and the "Original item order" arm using a between-groups t-test.
Measured: At enrollment
Secondary outcomes (1)
Difference in individual PHQ-8 somatic item mean scores when administered outside and within a depression questionnaire context
Scores obtained on the 8-item Patient Health Questionnaire (PHQ-8) range from 0 to 24, with higher scores indicating worse outcome. Individual items are scored on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). PHQ-8 somatic items will include items 3 (sleep problems), 4 (fatigue), and 5 (changes in appetite). The investigators will compare mean scores of each individual item between the "Reordered items" arm and the "Original item order" arm using 3 between-groups t-tests.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start17 Jan 2025
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett D Thombs, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772896
- Sponsor's protocol ID
- 2025-PHQ
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Questionnaire Context on the Reporting of Somatic Items in the 8-item Patient Health Questionnaire Among People With Systemic Sclerosis: A Scleroderma Patient-centered Intervention Network (SPIN) Study
- ClinicalTrials.gov ID
- NCT06772896
- Acronym / sponsor ID
- 2025-PHQ
- Keywords
- Scleroderma, Systemic Sclerosis, Depression, Patient-reported outcome measure, PROM, Item order
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is concern that self-reported depression questionnaires that contain items assessing somatic symptoms may result in biased scores in people with a chronic disease due to symptoms that overlap with their physical disease. However, it has been shown in previous studies that biases associated with somatic items do not affect total depression scores. The reason for this is still unclear but could be associated with the context in which these items are presented.
The goal of this experiment is to learn whether the way people with systemic sclerosis answer somatic items on a depression questionnaire is influenced by the fact that they are aware they are being assessed for depressive symptoms.
The main question it aims to answer is: Do people with systemic sclerosis score somatic items differently when they are administered outside the context of a depression questionnaire? Participants will be randomly assigned to complete the 8-item Patient Health Questionnaire as part of their routine cohort assessments either with the items in their standard order or with somatic items presented first and separately from psychological items.
Detailed description
- BACKGROUND Most self-report depression symptom questionnaires include both psychological and somatic symptom items. The 9-item Patient Health Questionnaire (PHQ-9) and its 8-item version (PHQ-8) are commonly used depression assessment measures and include items that reflect the psychological and somatic symptoms of depression listed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). However, there is concern that scores obtained using such questionnaires may be inflated in people with chronic illness due to the overlap of somatic symptoms related to depression and those stemming from their physical illness. In contrast to what might be expected, existing research suggests that having a medical illness or the severity of a respondent's medical illness are not associated with higher scores on somatic symptom items of the PHQ-9. Studies conducted in different patient populations, including people with systemic sclerosis (SSc), found either no significant differential item functioning (DIF) in somatic items of depression questionnaires or minimal DIF that did not significantly affect total questionnaire scores. It is possible that people with medical conditions who experience symptoms that may overlap with depression symptoms, including fatigue, changes in appetite, and sleep problems, do not report them on the PHQ-9 or PHQ-8 more than people without medical conditions due to a question ordering or context effect. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a randomized experiment to examine whether awareness that depression symptoms are being assessed affects how people with a chronic illness report somatic symptoms of depression.
- OBJECTIVES The primary objective will be to evaluate differences in mean sum scores of PHQ-8 somatic items (sum of item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite) in people with SSc when the items are administered outside the context of a depression questionnaire compared to when they are administered in the context of a depression questionnaire. The secondary objective will be to evaluate differences in mean scores for each individual somatic symptom item.
- RECRUITMENT The SPIN Cohort is a large multinational cohort that collects longitudinal data on patient-reported outcomes from people living with SSc. It currently includes >1500 active participants recruited from 53 SPIN sites in Canada, the United States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN cohort participants are recruited during regular medical visits at SPIN recruitment sites, and written informed consent is obtained. Once enrolled in the Cohort, participants are sent an automated welcome email with instructions on how to activate their SPIN account and complete SPIN Cohort measures online. Cohort participants complete online assessments upon enrolment and at 3-month intervals. All SPIN Cohort participants who log in to the SPIN Cohort platform to complete a routine 3-month assessment will be included in this experiment.
- RANDOMIZATION The SPIN Cohort platform will be programmed to automatically randomize each participant via simple randomization in a 1:1 ratio to either the "Reordered items" arm or the "Original item order" arm.
- OUTCOMES The primary outcome variable will be the sum score of the 3 PHQ-8 somatic symptom item scores (item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite). The secondary outcome variables will be the individual item scores for items 3, 4, and 5.
- METHODS This is a two-arm parallel randomized controlled experiment. When SPIN Cohort participants log in to complete their routine assessment, they will be randomly assigned to complete either the standard PHQ-8 or a reordered version in which the 3 somatic symptom items (item 3 = sleep disturbances, item 4 = fatigue, and item 5 = changes in appetite) will be presented first, without any indication that they are part of a depression questionnaire, and the psychological symptom items will be presented later in the assessment protocol. Both primary and secondary analyses will be done as complete case analyses using between-groups t-tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reordered items | Experimental | Other: Reordered PHQ-8Participants will receive a routine assessment protocol in which the 3 PHQ-8 somatic items will be presented separately from and prior to the 5 psychological items, without any indication they are part of a depression symptom questionnaire. PHQ-8 psychological items will be presented after the somatic items and with at least 1 measure separating them in the routine assessment protocol. With the exception of these 2 rules, all measures included in the routine assessment will appear in a random order for each SPIN Cohort participant. |
| Original item order | No intervention | –Participants will complete the standard version of the PHQ-8 which includes both somatic and psychological items, presented in a random order among other measures of the routine assessment protocol. The title of the PHQ-8 will not be included and participants will only see the 8 items presented on a single page in their standard order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English, French or Spanish.
- Participants must have access to a computer or tablet with internet access.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reordered PHQ-8Participants will be administered the PHQ-8 somatic items separately from the psychological items, outside the context of a depression questionnaire. | Other | Reordered items |
Primary outcome
Difference in mean sum PHQ-8 somatic item scores when administered outside and within a depression questionnaire context
Time frame: At enrollment
Scores obtained on the 8-item Patient Health Questionnaire (PHQ-8) range from 0 to 24, with higher scores indicating worse outcome. Individual items are scored on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). PHQ-8 somatic items will include items 3 (sleep problems), 4 (fatigue), and 5 (changes in appetite). The investigators will compare the mean sum score of somatic item scores between the "Reordered items" arm and the "Original item order" arm using a between-groups t-test.
1 secondary outcome
Difference in individual PHQ-8 somatic item mean scores when administered outside and within a depression questionnaire context
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reordered PHQ-8 in people with Scleroderma and Systemic Sclerosis (SSc), run by Lady Davis Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean sum PHQ-8 somatic item scores when administered outside and within a depression questionnaire context (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.